Alembic Pharma Clears ANVISA Audit At Karakhadi API Facility With Zero Observations

The inspection, conducted by Brazil’s health regulator ANVISA, focused on compliance with GMP standards at Alembic’s Karakhadi API-III site. The facility, which handles several APIs for regulated markets, passed the audit cleanly a positive outcome for its global filings and supply continuity.

ANVISA Inspection Details

The Brazilian Health Regulatory Agency carried out the GMP inspection at the API-III facility in Karakhadi over multiple days and concluded it without any observations, covering dozens of APIs manufactured at the site. This outcome indicates full compliance with Brazil’s stringent quality and documentation standards.

Regulatory Significance For Alembic

A zero-observation ANVISA audit strengthens Alembic’s position in Latin American markets and supports ongoing and future product registrations in Brazil. It also underscores the robustness of its quality systems at a time when global regulators are increasingly vigilant on API supply chains.

Broader Compliance Track Record

The Karakhadi API-III facility has also recently cleared a scheduled USFDA GMP inspection with zero Form 483 observations, further validating its global compliance standards and reinforcing Alembic’s credibility as a supplier to heavily regulated markets.

Key Highlights

• ANVISA GMP inspection at API-III Karakhadi completed without observations
• Audit covered multiple APIs meant for Brazil and regulated markets
• Strengthens Alembic’s regulatory standing in Latin America
• Karakhadi API-III facility also cleared recent USFDA GMP inspection with zero observations

Sources: Company regulatory filings, stock exchange disclosures, media reports